A PET Study With RO5545965 in Healthy Male Volunteers

A Single Centre, Open Label Study to Characterize the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 After a Single Dose in Healthy Male Volunteers Using [11C]IMA107 Positron Emission Tomography

This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission tomography (PET).

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: RO5545965

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects, 25 to 50 years of age, inclusive; healthy status is defined by absence of evidence of any active or chronic disease
• Body mass index (BMI) 18 to 30 kg/m2 inclusive
• Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method (i.e. condom), for the duration of the study and for 30 days after the last dose

Exclusion Criteria:

• History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, haematological or allergic disease, metabolic disorder, cancer or cirrhosis
• History of clinically significant hypersensitivity or allergic drug reactions
• Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
• Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
• Positive for hepatitis B, hepatitis C, or HIV infection
• Evidence of significant cardiovascular disease or disorder
• Participation in an investigational drug or device study within 3 months prior to first administration of the study drug or within 6 times the elimination half-life, whichever is longer
• Previous inclusion in a research and/or medical protocol or any clinical procedures involving nuclear medicine, PET, occupational exposure to ionizing radiation or radiological investigations with significant exposure to radiation, excluding dental X-ray and common X-rays of chest or extremities
• Subject has any condition that would prevent an MRI from accurately or safely being performed [eg, claustrophobia, cardiac pacemaker, metallic implants or clips]
• Subject unable to lie on his back in the PET or MRI scanner for a period of 90 minutes
• Contraindication for arterial cannulation
• Unsuitable veins for repeated venipuncture

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RO5545965	Drug: RO5545965; Single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamics: Brain PDE10 occupancy by RO5545965	up to Day 2
PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations	up to Day 2

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	up to 12 days
Pharmacokinetics: Plasma concentrations of RO5545965	up to Day 5

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (ESTIMATE): August 14, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: BP28844; 2013-000538-36 (EUDRACT_NUMBER)